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NCT02659540 · ClinicalTrials.gov registry record · Phase 1

Pilot Study of the Safety/Efficacy of Combination Checkpoint Blockade + External Beam Radiotherapy in Stage IV Melanoma

A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT02659540: Completed Phase 1 study, sponsored by Ludwig Institute for Cancer Research.

NCT02659540 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02659540, a Phase 1 study, has completed, sponsored by Ludwig Institute for Cancer Research.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

This is an ongoing, Phase 1, open-label, multicenter, pilot study of the checkpoint antibodies ipilimumab and nivolumab in combination with radiotherapy (RT) in 18 subjects with unresectable Stage IV melanoma. The primary study objective is to evaluate the safety of study treatment. Secondary objectives are to evaluate objective response rate (ORR) and disease control rate (DCR) at Weeks 12 and 18, duration of response, progression-free survival (PFS), and overall survival (OS).

Primary Outcome

Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 100 days after the last dose of study treatment. Treatment-emergent AEs were those that occurred or worsened after admini

Interventions

  • DRUG Nivolumab
  • DRUG Ipilimumab
  • RADIATION Radiotherapy

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2016-10-13
Est. Completion 2020-07-27
Phase Phase 1

What the finished NCT02659540 record still lists

NCT02659540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.

NCT02659540 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02659540 about?

NCT02659540 is a clinical study titled "Pilot Study of the Safety/Efficacy of Combination Checkpoint Blockade + External Beam Radiotherapy in Stage IV Melanoma". This is an ongoing, Phase 1, open-label, multicenter, pilot study of the checkpoint antibodies ipilimumab and nivolumab in combination with radiotherapy (RT) in 18 subjects with unresectable Stage IV melanoma. The primary study objective is to evaluate the safety of study treatment. Secondary object...

What is the current status of trial NCT02659540?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2016-10-13. Estimated completion is 2020-07-27.

What interventions are being tested in trial NCT02659540?

The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Radiotherapy (RADIATION).

Who is sponsoring clinical trial NCT02659540?

This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02659540's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02659540, the US trial registry maintained by the National Library of Medicine. NCT02659540 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.